Inflammation in Vascular Disease (REBEL)

The Role of Inflammation in Vascular Disease (Inflammationens Roll i kärlsjukdom)

Increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. Thus, we will investigate the role of inflammation in cardiovascular disease.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Atherosclerosis

Detailed Description

Vascular reconstruction surgeries usually require a small piece of the vessel wall to be excised. The excised vessel is generally discarded as medical waste: however, for patients participating in the study, the excised tissue will be placed in saline and collected for research use.

Tissue collected from individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue will be cultured ex vivo in the presence or absence of therapeutic agents, to determine if these attenuate the inflammation associated with the atherosclerotic phenotype. Furthermore, the protocol will also be carried out using vascular tissue from control patients, which have undergone vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc).

• Study Type: Observational
• Enrollment (Anticipated): 170

Contacts and Locations

• Study Contact: Name: Emma Borgeson, PhD; Phone Number: +46313420000; Email: emma.borgeson@wlab.gu.se
• Study Contact Backup: Name: Per Skoog, MD, PhD; Phone Number: +46313420000; Email: per.skoog@vgregion.se

Study Locations

• Sweden
  • Vastragotaland
    • Gothenburg, Vastragotaland, Sweden, 40530
      • Recruiting
      • University of Gothenburg
      • Contact: Emma Borgeson, PhD; Phone Number: +4631342000
      • Contact: Per Skoog, MD, PhD; Phone Number: +4631342000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients planned for vascular reconstruction surgery at our center.

Description

Inclusion Criteria:

• Patient is planned to undergo vascular surgery.
• Signed informed consent has been obtained from the patient.

Exclusion Criteria:

• Patient has difficulty to understand information.
• Patients under 18 years of age.
• Patients participating in any drug-related study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control patients; Control patients (n=20): In individuals undergoing vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc), a piece of healthy vessel must sometimes be removed in order to facilitate the surgical process. The vessel biopsies from this group will be categorized as "healthy vessels" in our study.
Study patients; Study patients (n=150): In individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue is sometimes excised to facilitate the surgery. Biopsies from these individuals will be categorized as "vessels with vascular dysfunction".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory status	The inflammatory status will be studied in patients with atherosclerotic disease.	2019-2024

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Study Director: Jan Boren, MD, PhD, The University of Gothenburg

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Inflammation; Atherosclerosis
• Other Study ID Numbers: 660-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No